Quality Engineer

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with employer match

PTO 20 days (+ milestones)

3 personal days

Comprehensive benefits (health, dental

Employee discount program

Safety and Quality priority

Career advancement opportunities

Paid maternity and parental leave

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Quality Engineer to lead the creation and maintenance of control groups and inspector training sets.

You will review investigations for quality events, ensure SOP compliance, and drive continuous improvement in manufacturing processes, with responsibility for Change Controls and related documentation. Ideal candidates have a science/engineering background, 3–5 years GMP experience, and strong project leadership skills to guide quality projects from

Qualifications

• Must have excellent verbal and written communication skills.
• Ability to manage and complete projects.
• Experience in GMP regulations is a plus.

Responsibilities

• Generate control group samples for newly commissioned/validated inspection lines.
• Generate control group samples for established inspection lines.
• Recertify samples within required timelines.
• Generate and maintain Inspector Training Sets.
• Update SOPs/Work Instructions to reflect control group additions/revisions.
• Issue samples to Inspection and Packaging.
• Coordinate with Operations to schedule time to certify samples.
• Coordinate with Operations to schedule water/placebo runs as needed.
• Review, revise and approve investigations to ensure compliance and timely product release.
• Provide direction for process improvements or preventative measures.
• Gather, assess, and distribute daily, weekly and monthly metrics.
• Perform QA Investigations or other assigned investigations.
• Revise and train individuals on SOPs relating to investigation processes.
• Identify and implement quality improvement projects.
• Lead projects to completion with minimal supervision.
• Review and approve Quality documents such as SOPs, Change Controls, QTO protocols and GTRs

Skills

Communication skills

Analytical thinking

Teamwork

Project management

Independent work

Education

Bachelor’s degree in science/engineering

Job description

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB SUMMARY:

The primary focus of this position is the creation and maintenance of control groups and inspector training/qualification sets. Other tasks may include review of investigations for quality related events triggered through the manufacturing process. Provide feedback to the investigation writer on the quality of the report with emphasis on compliance to SOP’s and cGMP. Must be the subject matter expert in the auditing/investigative process and provide the necessary leadership to assure continuous improvement in the mitigation of events associated with the manufacturing process. Independently lead Quality Engineering projects including identification of projects, definition of project scope, writing Change Controls, creating Engineering required documentation, and project tracking. Review and approve Quality documents such as SOPs, Change Controls, and QTO protocols, GTRs, Engineering Drawings, Maintenance Work Requests/Work orders, Inspector Qualification/Re-qualification, and challenge group creation and maintenance.

RESPONSIBILITIES:

• Generate control group samples for newly commissioned / validated inspection lines
• Generate control group samples for established inspection lines
• Recertify samples within required timelines
• Generate and maintain Inspector Training Sets
• Ensure SOPs / Work Instructions are updated to reflect control group additions / revisions
• Issue samples to Inspection and Packaging
• Coordinate with Operations to schedule time to certify samples
• Coordinate with Operations to schedule water / placebo runs as needed
• Review, revise and approve investigations in a timely manner to ensure compliance and timely product release and internal deadlines are met.
• Individual to provide direction for process improvements or preventative measures to avoid or minimize process deviations consistent with business requirements.
• Gather, assess, and distribute daily, weekly and monthly metrics.
• Perform QA Investigations or other assigned investigations as required.
• Revise and train individuals on the SOP's relating to the investigation process. Participates in the development and delivery of training/refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary.
• Identify and implement quality improvement projects.
• Lead projects to completion with minimal supervision. i.e., coordinate manual inspector training program and challenge group program.
• Review and approve Quality documents such as SOPs, Change Controls, QTO protocols and GTRs

QUALIFICATIONS:

• Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk.
• Resourceful, self-reliant, self-motivated and confident. Ability to work independently and be flexible to changing priorities. Strong personal computer skills.
• Must have excellent teamwork and organizational skills.
• Must have Science /Engineering background and demonstrated ability to manage and complete projects.

EDUCATION/EXPERIENCE:

• Bachelor’s degree in science/engineering with experience in an engineering or scientific (pharmaceutical manufacturing) discipline.
• 3 to 5 years experience in the areas of GMP regulations.
• Previous auditing experience is a plus.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.